Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473122
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2007-05-10
Brief Title:
Delayed-Immediate Breast Reconstruction
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Delayed-Immediate Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to evaluate a new two-stage approach delayed-immediate reconstruction to breast reconstruction in women who may require post-mastectomy radiation therapy Researchers will compare the cosmetic outcomes and any complications that occur in women who receive delayed-immediate reconstruction to those who receive the standard approaches either immediate reconstruction or delayed breast reconstruction
Detailed Description:
In women who have a mastectomy and desire breast reconstruction the best timing of breast reconstruction depends on whether radiation therapy XRT is needed If XRT is not needed immediate reconstruction offers the best cosmetic result However if XRT is needed it is better to delay reconstruction until XRT is complete There are 2 reasons to wait First the presence of a reconstructed breast can interfere with the delivery of XRT decreasing the effectiveness of this treatment Second exposing a reconstructed breast to radiation can cause poor cosmetic results Today many women are not offered immediate reconstruction because it is not known at the time of their mastectomy whether they will need XRT Researchers believe that for such women a new approach called delayed-immediate reconstruction will offer the cosmetic benefits of immediate reconstruction without the potential drawbacks of ineffective treatment
If you agree to take part in this study you will have your already scheduled skin-sparing mastectomy However at the time of your routine mastectomy you will also have a tissue expander or postoperatively adjustable implant fully inflated with saline or as allowed by the remaining capacity space of the retained breast skin placed in your breast Some patients will have a small biopsy of skin that is normally discarded done so that scientists can learn about changes and ways of healing after radiation When the final pathology report is complete about 1 week after mastectomy the radiation doctor andor your surgeon will decide whether or not you need XRT
If the results show that you do not need XRT you will have the tissue expander or implant removed and will have standard definitive breast reconstruction using the preserved breast skin about 2 weeks after mastectomy The reconstructive technique used will be decided based on anatomical considerations surgical factors and your personal desires The postoperative follow-up will be similar to that of patients who have standard immediate breast reconstruction
If the results show that you do need XRT the tissue expander or adjustable implant will be completely deflated in the plastic surgery clinic before you receive standard XRT Radiation must be given either at MD Anderson or an MD Anderson-affiliated site Deflation of the tissue expander or implant will result in a flat chest wall that will decrease difficulties with radiation delivery that can occur after an immediate breast reconstruction If you also require chemotherapy after mastectomy the tissue expander or implant will remain inflated during chemotherapy additional saline-filling may also be performed during chemotherapy if required In patients who have already received chemotherapy before mastectomy or who will not require chemotherapy the expander or implant will remain inflated during the 4-to-6-week period between mastectomy and XRT About 3 weeks into your radiation treatments you will come in to the plastic surgery clinic for a follow-up to check on the status of the implants
Several weeks after the completion of XRT the tissue expander or postoperatively adjustable implant will be gradually re-expanded over about 6-months The internal scar capsule that forms around the tissue expander or implant before deflation usually allows for re-expansion after radiation therapy Re-expansion after radiation therapy will be performed during postoperative visits to the plastic surgery clinic every 2-to-4 weeks until the desired size is achieved About 6 months after the completion of XRT a skin-preserving delayed reconstruction with a preference for autologous tissues only no breast implants will be performed This will involve removal of the tissue expander or implant and definitive breast reconstruction At the time of the skin-preserving delayed reconstruction a small biopsy of usually thrown away radiated breast tissue as well as a sample of the skin that is normally discarded of the flap your tissue that is taken from your back stomach or buttock to build the breast and a sample of the implant or tissue expander will be collected for laboratory evaluation Researchers will evaluate the skin changes from radiation and expansion as well as from the internal scar capsule This will be compared to radiated skin biopsies without expansion and biopsies taken after skin expansion without radiation
Your medical information and photographs of your breasts will be gathered throughout the various stages of delayed-immediate reconstruction
Delayed-immediate breast reconstruction is a two-stage approach and as such involves at least 2 surgical procedures This does not include the possibility of procedures needed to modify the reconstructed breast a procedure on the healthy breast to make it symmetrical similar in appearance and size with the reconstructed breast and any nipple reconstruction and areolar tattooing that may be needed If later on it is necessary to revise the reconstructed breast a small skin sample smaller than a pencil eraser will again be collected for additional studies This will not affect the outcome of your surgery or the way your breast will look
The postoperative course follow-up and the need for additional surgical procedures will be decided in a similar fashion to that of standard immediate and delayed breast reconstruction
This is an investigational study The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction They are not specifically approved for both expansion and radiation About 200 women will take part in this study All will be enrolled at MD Anderson Cancer Center MDACC
If you agree to take part in this study you will have your already scheduled skin-sparing mastectomy However at the time of your routine mastectomy you will also have a tissue expander or postoperatively adjustable implant fully inflated with saline or as allowed by the remaining capacity space of the retained breast skin placed in your breast Some patients will have a small biopsy of skin that is normally discarded done so that scientists can learn about changes and ways of healing after radiation When the final pathology report is complete about 1 week after mastectomy the radiation doctor andor your surgeon will decide whether or not you need XRT
If the results show that you do not need XRT you will have the tissue expander or implant removed and will have standard definitive breast reconstruction using the preserved breast skin about 2 weeks after mastectomy The reconstructive technique used will be decided based on anatomical considerations surgical factors and your personal desires The postoperative follow-up will be similar to that of patients who have standard immediate breast reconstruction
If the results show that you do need XRT the tissue expander or adjustable implant will be completely deflated in the plastic surgery clinic before you receive standard XRT Radiation must be given either at MD Anderson or an MD Anderson-affiliated site Deflation of the tissue expander or implant will result in a flat chest wall that will decrease difficulties with radiation delivery that can occur after an immediate breast reconstruction If you also require chemotherapy after mastectomy the tissue expander or implant will remain inflated during chemotherapy additional saline-filling may also be performed during chemotherapy if required In patients who have already received chemotherapy before mastectomy or who will not require chemotherapy the expander or implant will remain inflated during the 4-to-6-week period between mastectomy and XRT About 3 weeks into your radiation treatments you will come in to the plastic surgery clinic for a follow-up to check on the status of the implants
Several weeks after the completion of XRT the tissue expander or postoperatively adjustable implant will be gradually re-expanded over about 6-months The internal scar capsule that forms around the tissue expander or implant before deflation usually allows for re-expansion after radiation therapy Re-expansion after radiation therapy will be performed during postoperative visits to the plastic surgery clinic every 2-to-4 weeks until the desired size is achieved About 6 months after the completion of XRT a skin-preserving delayed reconstruction with a preference for autologous tissues only no breast implants will be performed This will involve removal of the tissue expander or implant and definitive breast reconstruction At the time of the skin-preserving delayed reconstruction a small biopsy of usually thrown away radiated breast tissue as well as a sample of the skin that is normally discarded of the flap your tissue that is taken from your back stomach or buttock to build the breast and a sample of the implant or tissue expander will be collected for laboratory evaluation Researchers will evaluate the skin changes from radiation and expansion as well as from the internal scar capsule This will be compared to radiated skin biopsies without expansion and biopsies taken after skin expansion without radiation
Your medical information and photographs of your breasts will be gathered throughout the various stages of delayed-immediate reconstruction
Delayed-immediate breast reconstruction is a two-stage approach and as such involves at least 2 surgical procedures This does not include the possibility of procedures needed to modify the reconstructed breast a procedure on the healthy breast to make it symmetrical similar in appearance and size with the reconstructed breast and any nipple reconstruction and areolar tattooing that may be needed If later on it is necessary to revise the reconstructed breast a small skin sample smaller than a pencil eraser will again be collected for additional studies This will not affect the outcome of your surgery or the way your breast will look
The postoperative course follow-up and the need for additional surgical procedures will be decided in a similar fashion to that of standard immediate and delayed breast reconstruction
This is an investigational study The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction They are not specifically approved for both expansion and radiation About 200 women will take part in this study All will be enrolled at MD Anderson Cancer Center MDACC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCTR0503938 | OTHER | Susan G Komen Breast Cancer Foundation | None |
| NCI-2012-02091 | REGISTRY | None | None |